Breast Cancer Clinical Trial

The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial

Summary

Primary Hypothesis:

1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction

Secondary hypotheses:

The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not require radiation.
Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.
Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix

Specific aims:

Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation
Compare the complication rates between the two types of acellular dermal matrix
Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.
Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy
Female gender
Age between 18 and 80
Consent to participate in the study

Exclusion Criteria:

Patients not undergoing breast reconstruction following mastectomy
Patients undergoing delayed breast reconstruction following mastectomy
Patients undergoing immediate definitive breast reconstruction after mastectomy
Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction
Medical debility precluding surgical treatment
Prior breast or chest wall irradiation
Pregnant patients
Male gender

Study is for people with:

Breast Cancer

Phase:

Phase 4

Estimated Enrollment:

128

Study ID:

NCT00872859

Recruitment Status:

Completed

Sponsor:

University of Utah

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There is 1 Location for this study

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University of Utah Hospital/ Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 4

Estimated Enrollment:

128

Study ID:

NCT00872859

Recruitment Status:

Completed

Sponsor:


University of Utah

How clear is this clinincal trial information?

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